iGFBP-1 Rapid Test Strip

IGFBP-1 means insulin-like growth factor-binding protein 1. It is also known by names such as IGF-binding protein 1, placental protein 12, and amniotic fluid binding protein. In pregnancy care, the iGFBP-1 Rapid Test Strip is used because IGFBP-1 can act as a useful biomarker when amniotic fluid is present in vaginal secretion. This makes the test relevant for suspected rupture of fetal membranes, especially when clinical signs are uncertain.

The iGFBP-1 Rapid Test Strip by LARKSOIS Pharma is intended for the qualitative detection of IGFBP-1 in vaginal secretion samples during pregnancy. It is used as a rapid screening aid in suspected PROM or ROM cases.

Applications

• Suspected rupture of fetal membranes
• Premature rupture of membranes assessment support
• Obstetric emergency evaluation
• Maternity ward testing
• Labor and delivery units
• Gynecology and pregnancy-care clinics
• Diagnostic laboratory support
• International maternal-care product distribution

The iGFBP-1 Rapid Test Strip uses the colloidal gold method, a rapid immunochromatographic testing principle. In this method, gold-labeled antibodies interact with IGFBP-1 in the sample. If IGFBP-1 is present at or above the detection level, a visible test line appears on the strip.

Benefits

• Simple strip-based format
• Fast visual result interpretation
• No complex instrument required
• Suitable for maternity and emergency settings
• Easy sample workflow
• Professional point-of-care screening support
• Practical for international diagnostic supply

The correct sample for the iGFBP-1 Rapid Test Strip is vaginal secretion or cervicovaginal secretion. Urine should not be listed as the specimen unless LARKSOIS Pharma has a separate validated urine-based product, which is not typical for PROM IGFBP-1 testing.

Guidance

• Collect vaginal secretion using the recommended sterile swab
• Follow the product IFU carefully
• Avoid contaminated samples
• Avoid lubricants or antiseptics unless allowed by the IFU
• Perform testing by trained healthcare professionals
• Read results within the approved time window
• Do not reuse the strip

Note

Proper sample collection is important because vaginal fluid may be affected by blood, mucus, infection, vaginal medications, or improper collection technique.

• PROM means rupture of membranes before labor begins. It can increase the risk of complications, especially if it occurs before term.
• Accurate PROM assessment helps healthcare professionals decide whether the patient needs monitoring, admission, infection-risk management, fetal assessment, or further obstetric care.
• The iGFBP-1 Rapid Test Strip helps support PROM evaluation by detecting a biomarker associated with amniotic fluid leakage. It is useful when membrane rupture needs quick clinical evaluation.

Steps

• Bring the test strip and collected sample to the recommended testing condition
• Open the sealed pouch only when ready to test
• Collect vaginal secretion using the recommended sterile swab
• Prepare the sample according to the product IFU
• Dip or apply the sample to the strip according to instructions
• Place the strip on a clean, flat surface if required
• Read the result within the approved time window

Note

The exact procedure must follow the official LARKSOIS Pharma product insert or IFU supplied with the iGFBP-1 Rapid Test Strip.

Positive

A positive result usually means IGFBP-1 has been detected in the vaginal secretion sample. This may suggest amniotic fluid leakage and possible rupture of fetal membranes. The result should be reviewed by a healthcare professional.

Negative

A negative result usually means IGFBP-1 is not detected or is below the test’s detection level. This may support intact membranes, but clinical judgment is still required if symptoms continue.

Invalid

If the control indicator does not appear, the test is invalid. The test should be repeated with a new iGFBP-1 Rapid Test Strip and fresh sample according to the product IFU.

Instructions

• Store in a clean and dry place
• Keep away from direct sunlight
• Do not freeze unless stated on the label
• Keep sealed until use
• Do not use damaged pouches
• Do not use after expiry date
• Dispose of used materials according to local medical-waste rules

Instructions

• For professional diagnostic use only
• Use vaginal secretion or cervicovaginal secretion samples only
• Do not use urine as the specimen unless specifically validated by the product IFU
• Do not reuse the strip
• Do not use expired or damaged test strips
• Clinical decisions should not rely only on the test result
• Results should be interpreted by trained healthcare professionals with clinical findings
• Follow local pregnancy-care and obstetric diagnostic guidelines

LARKSOIS Pharma provides diagnostic products for international healthcare markets with a focus on reliable product positioning, professional usability, and global supply needs. The iGFBP-1 Rapid Test Strip (Vaginal Secretion) is designed for maternal-care settings where fast and practical screening support is required.

Advantages

• Vaginal secretion-based PROM screening support
• Colloidal gold rapid test method
• Compact strip format
• Simple visual result interpretation
• Suitable for hospitals and maternity clinics
• Useful for obstetric emergency evaluation
• International product positioning under LARKSOIS Pharma